Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies.
Millie D Long, Stefan Schreiber, Toshifumi Hibi, Theresa Hunter Gibble, Deborah A Fisher, Gina Park, Richard E Moses, Peter D R Higgins, James O Lindsay, Scott D Lee, Rodrigo Escobar, Vipul Jairath
Author Information
Millie D Long: Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.
Stefan Schreiber: Department Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Toshifumi Hibi: Kitasato Institute Hospital, Minato-ku, Center for Advanced IBD Research and Treatment, Tokyo, Japan.
Theresa Hunter Gibble: Eli Lilly and Company, Indianapolis, IN, USA. ORCID
Deborah A Fisher: Eli Lilly and Company, Indianapolis, IN, USA.
Gina Park: Techdata Services Company LLC, King of Prussia, PA, USA.
Richard E Moses: Eli Lilly and Company, Indianapolis, IN, USA.
Peter D R Higgins: Department of Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, MI, USA.
James O Lindsay: Barts Health NHS Trust, London, UK.
Scott D Lee: Division of Gastroenterology, University of Washington Medical Center, Seattle, WA, USA.
Rodrigo Escobar: Eli Lilly and Company, Indianapolis, IN, USA.
Vipul Jairath: Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada. ORCID
Background: Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality-of-life (QoL) outcomes. Methods: LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200 mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, the association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. Results: A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, < .0001; W52: 91.4% vs 45.5%, p < .0001). Similarly, BU Remission was associated with more patients achieving CMI in SF-36 Physical Component Summary (W12: 69.0% vs 44.4%, < .0001; W52: 77.5% vs 42.1%, < .0001) and Mental Component Summary (W12: 53.5% vs 41.0%, = .0019; W52: 62.0% vs 38.3%, < .0001) scores. At W12 and W52, patients with BU CMI or Remission showed significant improvements in EQ-5D-5L and Work Productivity and Activity Impairment:UC scores. Significant improvements were also seen in fatigue, abdominal pain, and nocturnal stool. Conclusions: In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies. Clinical Studies: LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.
